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Gastrointestinal Endoscopy

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A multicenter, prospective, randomized comparison of a novel signal transmission capsule endoscope to an existing capsule endoscope - 17/07/13

Doi : 10.1016/j.gie.2013.02.039 
Eric H. Choi, MD 1, ⁎, Klaus Mergener, MD, PhD, MBA 2, Carol Semrad, MD 3, Laurel Fisher, MD 4, David R. Cave, MD 5, Milan Dodig, MD 6, Carol Burke, MD 6, Jonathan A. Leighton, MD 7, David Kastenberg, MD 8, Peter Simpson, MD 9, James Sul, MD 10, Kanishka Bhattacharya, MD 5, Roger Charles, MD 11, Lauren Gerson, MD, MSc 12, Luke Weber, MD 6, Glenn Eisen, MD 13, Warren Reidel, MD 14, John J. Vargo, MD 6, Jamile Wakim-Fleming, MD 6, Simon K. Lo, MD 15
1 Division of Gastroenterology and Hepatology, Riverside Medical Clinic, Riverside, California, USA 
2 Division of Gastroenterology and Hepatology, Digestive Health Specialist, Tacoma, Washington, USA 
3 Division of Gastroenterology and Hepatology, University of Chicago, Chicago, Illinois, USA 
4 Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA 
5 Division of Gastroenterology and Hepatology, University of Massachusetts, Worchester, Massachusetts, USA 
6 Division of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, Ohio, USA 
7 Division of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Scottsdale, Arizona, USA 
8 Division of Gastroenterology and Hepatology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA 
9 Division of Gastroenterology and Hepatology, Camino Medical Group, Mountain View, California, USA 
10 Division of Gastroenterology and Hepatology, University of California at Los Angeles, Los Angeles, California, USA 
11 Division of Gastroenterology and Hepatology, Cleveland Clinic, Florida, Weston, Florida, USA 
12 Division of Gastroenterology and Hepatology, Stanford University, Palo Alto, California, USA 
13 Division of Gastroenterology and Hepatology, Oregon Health & Science University, Portland, Oregon, USA 
14 Division of Gastroenterology and Hepatology, Scripps Clinic, La Jolla, California, USA 
15 Division of Gastroenterology and Hepatology, Cedars Sinai Medical Center, Los Angeles, California, USA 

∗Reprint requests: Eric H. Choi, MD, 6405 Day Street, Riverside, CA 92507.

Abstract

Background

MiroCam, a capsule endoscope, uses a novel transmission technology, electric-field propagation, which uses the human body as a conduction medium for data transmission.

Objective

To compare the ability of the MiroCam (MC) and PillCam (PC) to identify sources of obscure GI bleeding (OGIB).

Design

Prospective, multicenter, comparative study.

Setting

Six academic hospitals.

Patients

A total of 105 patients with OGIB.

Intervention

Patients ingested both the MC and PC capsules sequentially in a randomized fashion.

Main Outcome Measurements

Concordance of rates in identifying a source of OGIB, operational times, and rates of complete small-bowel examination.

Results

Data analysis resulted in 43 (48%) “abnormal” cases identifying a source of OGIB by either capsule. Twenty-four cases (55.8%) were positive by both capsules. There was negative agreement in 46 of 58 cases (79.3%). The κ index was 0.547 (χ2 = 1.32; P = .36). In 12 cases, MC positively identified a source that was not seen on PC, whereas in 7 cases, PC positively identified a source that was not seen on MC. MC had a 5.6% higher rate of detecting small-bowel lesions (P = .54). MC captured images at 3 frames per second for 11.1 hours, and PC captured images at 2 frames per second for 7.8 hours (P < .0001). Complete small-bowel examination was achieved in 93.3% for MC and 84.3% for PC (P = .10).

Limitations

Readers were not blinded to the particular capsule they were reading.

Conclusion

A positive diagnostic finding for OGIB was identified by either capsule in 48% of cases. The concordance rate between the 2 capsules was comparable to that of prior studies in identifying sources of small-bowel bleeding. The longer operational time of the MC may result in higher rates of complete small-bowel examination, which may, in turn, translate into a higher rate of detecting small-bowel lesions. (Clinical trial registration number: NCT00878982.)

Il testo completo di questo articolo è disponibile in PDF.

Abbreviations : CE, MC, OGIB, PC


Mappa


 DISCLOSURE: K. Mergener is a consultant for Intromedic, a speaker for Olympus, and a researcher for Capsovision. D. Cave works with Given Imaging. J. Leighton does research and consulting for Given Imaging, consulting for Olympus, and research for Capsovision. K. Bhattacharya received grant support from GI Dynamic and does consulting for Olympus. J. Vargo is a consultant for Boston Scientific, Cook Medical, Ethicon EndoSurgery, GEye Cue Ltd, and Olympus America. S. Lo is a speaker for Abbott. No other financial relationships relevant to this publication were disclosed.


© 2013  American Society for Gastrointestinal Endoscopy. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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Vol 78 - N° 2

P. 325-332 - agosto 2013 Ritorno al numero
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